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510(k) Data Aggregation

    K Number
    K100489
    Device Name
    DXH 300 COULTER CELLULAR ANALYSIS SYSTEM, DXH 300C COULTER CELLULAR ANALYSSI SYSTEM MODEL: 71772, 71771
    Date Cleared
    2010-10-26

    (249 days)

    Product Code
    Regulation Number
    864.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    BECKMAN COULTER CELLULAR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DxH 300 COULTER Cellular Analysis System and the DxH 300C COULTER Cellular Analysis System are quantitative automated hematology analyzers for in vitro diagnostic use in clinical laboratories. The DxH 300 COULTER Cellular Analysis System and the DxH 300C COULTER Cellular Analysis System provide complete blood count, (WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV) and Leukocyte 3-Part Differential [LY (%/#), MO (%/#), GR (%/#)] for whole blood specimens, collected in a salt of EDTA [dipotassium (K2) or tripotassium (K3)] obtained by venipuncture, heel or fingerstick. The purpose of the DxH 300 and the DxH 300C is to identify normal human patients, with normal system-generated parameters, from patients whose results require additional studies.
    Device Description
    The DxH™ 300 and DxH™ 300C COULTER® Cellular Analysis Analyzers are intended for In Vitro Diagnostic clinical laboratories. The DxH 300C has the capability to process samples in an fferentials pos of the DxH 300 Systems are to separate the nomal patient, with all nomal system enreres, p who needs additional studies of any of these parameters. These studies measurem imatano somrical of the antyrer and a suice of anneliza marker ormulario m national beranters mored the securitment milled del dinam minutare de propriamente del minder desi Parameters: WBC, Lymph #, Mo #, Gran#, Lymph %, Mo%, Gran%, RBC, HGB, HCT%, MCV, MCH, MCHC, RDW, RDW- SD, PLT, MPV. two counting modes, whole blood and prediute mode. The two modes is the amount of sample of sample ar
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